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A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer
EU CTIS ID: 2023-504027-78-00
What this study is testing
1. To evaluate the safety of tobemstomig alone and in combination with tiragolumab, compared to atezolizumab
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- 2. Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium. Patients with squamous, sarcomatoid, micropapillary, and glandular variant histologies are eligible for inclusion in the study, provided that a urothelial component is present in the tumor specimen. Patients with other variant histologies or pure variant histologies are not eligible for inclusion in the study
- 3. Considered to be ineligible ("unfit") to receive platinum-based chemotherapy defined by one of the following criteria: • ECOG Performance Status of 0 with baseline GFR ≥ 15 mL/min/1.73 m2 and ≤ 30 mL/min/1.73 m2 • ECOG Performance Status of 1 or 2 with baseline GFR ≥ 15 mL/min/1.73 m2 and ≤ 45 mL/min/1.73 m2 • ECOG Performance Status of 0-2 with Grade ≥ 2 neuropathy • Patients for whom chemotherapy is not deemed appropriate
- 4. No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)
- 5. Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)
- 6. Availability of a representative leftover tumor specimen that meet the criteria outlined prior to study enrollment, and that is suitable for determination of programmed death-ligand 1 (PD-L1) status, and for stratification as assessed by a central laboratory
You likely can't join if
- 1. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 4 months after the final dose of tobemstomig, or 90 days after the final dose of tiragolumab
- 2. Glomerular filtration rate (GFR) < 15 mL/min/1.73 m2 as calculated through use of the chronic kidney disease epidemiology collaboration (CKD-EPI) equation or receiving dialysis
- 3. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- 4. History of leptomeningeal disease
- 5. Uncontrolled tumor-related pain. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures and uncontrolled or symptomatic hypercalcemia
- 6. Active or history of autoimmune disease or immune deficiency. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Active tuberculosis (TB) or acute or chronic active Epstein-Barr virus (EBV)
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Turkey
- Mexico
- United Kingdom
- United States
- China
- Australia
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Turkey; Mexico; United Kingdom; United States; China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.